Medtronic’s recalled devices are used for brain aneurysm treatment. The estimated prevalence of unruptured intracranial aneurysms (UIAs) in the general population is around 3.2%, with an annual risk of rupture of 2-10%, leading to subarachnoid hemorrhage (SAH). Image credit: Tada Images / Shutterstock
The US Food and Drug Administration (FDA) has tagged Medtronic’s recall of certain Pipeline Vantage embolisation devices as Class I following reports of four patient deaths.
A Class I recall is the most serious type, and designated by the FDA in cases where it concludes there is ‘reasonable probability’ that use or exposure to a given product will cause serious adverse health consequences or death.
The Medtronic Neurovascular recall involves the company’s Pipeline Vantage 027, compatible with 0.027″ inner diameter microcatheters, and Pipeline Vantage 021 for use with 0.021” microcatheters (with both models part of product lots from B317266 through B817292).
Used for treating aneurysms, the devices are inserted into the blood vessels through a small catheter and delivered to the aneurysm location, following which a small, braided tube is placed to block off blood flow to the bulging area.
Reports surfaced that in the affected product lots of both Pipeline Vantage models, there was a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during aneurysm procedures, resulting in incomplete wall apposition or braid deformation.
The issue has resulted in 13 reported injuries and four reports of death in relation to Pipeline Vantage 027, and four reported injuries but no deaths with respect to Pipeline Vantage 021. The reports prompted Medtronic’s issuance of an ‘urgent recall notice’ to affected customers in January 2025.
The FDA stated that all affected 027 model devices be quarantined and returned to Medtronic, while those using the 021 model should refer to Medtronic’s updated instructions for device use, which the company said includes revisions to help users achieve optimal device size selection and stent braid deployment to “reduce the risk of complications and patient harms” by lowering the incidence of incomplete wall apposition and/or braid deformation.
Medtronic’s revised instructions for Pipeline Vantage 021 add guidance around how physicians can best use a balance of device tension and compression to achieve adequate wall apposition with the device. The instructions also include warnings about the consequences of incomplete wall apposition and suboptimal deployment, along with a callout around the increased risk of braid deformation in females, especially in those younger than 45 years of age.
This month, Philips pulled its endovascular implant from the market after the device was hit with a Class I recall tag from the FDA.
A recent study published in the BMJ found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year period.
Email newsletter icon
Sign up for our daily news round-up!
Give your business an edge with our leading industry insights.